- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05478005
Function and Pain Following Knee Replacement
Comparison of Function and Pain Intensity in the Acute Stage Following Total Knee Replacement, Between Different Methods of Post-surgical Pain Relief
The goal of this interventional study is to compare pain management techniques (femoral nerve block, intra-articular block, none) in TKA patients. The main questions it aims to answer are:
- Are there differences in postoperative outcomes?
- Does preoperative quadriceps muscle strength predict early functional ability? Participants underwent TKA and assessments. Researchers compared pain management techniques to assess effects on postoperative outcomes and identified the importance of preoperative quadriceps muscle strength as a predictor of early functional ability. Further research is required to refine postoperative pain management strategies.
Study Overview
Status
Intervention / Treatment
Detailed Description
Total knee arthroplasty (TKA) is a frequently undertaken elective orthopedic intervention for severe knee osteoarthritis, frequently yielding postoperative discomfort and complications. Peripheral nerve blocks, notably femoral nerve blocks, are commonly utilized for analgesia but may transiently impede motor nerve function, weakening the quadriceps muscle. Intra-articular blocks offer a potential alternative to mitigate motor impairment. However, there exists a dearth of information regarding the comparative effectiveness of these methods with respect to short-term functional outcomes in the immediate postoperative phase following TKA.
Objectives: This study assesses functional outcomes, pain, quadriceps strength after TKA with femoral nerve block, intra-articular block, and a control group. It identifies predictors of postoperative functional ability.
Methods: 54 patients undergoing TKA were evaluated, measuring pre-op quadriceps strength, and utilizing the Oxford Knee Score for functionality. Post-op, we evaluated mobility using the Timed Up & Go, Elderly Mobility Scale, and Five Times Sit-to-Stand tests on POD 1 & 3/4. Pain levels, hospitalization, surgical duration, complications, and falls were also recorded.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michal Elboim- Gabyzon, Dr
- Phone Number: 972545968943
- Email: michal.elboim@gmail.com
Study Contact Backup
- Name: Mor Kliger Tendler
- Phone Number: 972503623303
- Email: mor.kliger@gmail.com
Study Locations
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Nahariya, Israel
- Galilee Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men and women, over the age of 18, electively assigned for primary knee replacement surgery.
- ASA score 1-3
Exclusion Criteria:
- Revision surgery
- Patients suffering from chronic pain syndrome or chronic opioid use.
- Patients with previous neurological deficits in the lower extremities.
- A cognitive state that does not allow signing of consent or understanding simple instructions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Femoral nerve block
Patients undergoing total knee arthroplasty received a single-shot femoral nerve block during the surgical procedure.
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Patients who receive a femoral nerve block during surgery, fill out a questionnaire and undergo a muscle strength test before surgery, undergo functional tests, a muscle strength test and are asked about pain intensity after surgery.
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Experimental: Intra-articular block
Patients undergoing total knee arthroplasty received a intra-articular block during the surgical procedure.
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Patients who receive an intra-articular block at the time of surgery, fill out a questionnaire and undergo a muscle strength test before surgery, undergo functional tests, a muscle strength test and are asked about pain intensity after surgery.
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No Intervention: Control group
Patients undergoing total knee arthroplasty and didn't receive pain block.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Timed up & go test
Time Frame: first and fifth day after the surgery
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Total time to arise from chair, walk 3 m, turn around, return to chair and sit down.
Two trials performed and the faster of the two is recorded to the nearest 10th of a second.
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first and fifth day after the surgery
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Change in Elderly mobility scale
Time Frame: first and fifth day after the surgery
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The EMS is a 20 point validated assessment tool for the assessment of frail elderly subjects. The EMS is measured on an ordinal scale of 0-20, when Scores under 10 - generally these patients are dependent in mobility manoeuvres; require help with basic ADL, such as transfers, toileting and dressing. Scores between 10 - 13 - generally these patients are borderline in terms of safe mobility and independence in ADL i.e. they require some help with some mobility manoeuvres. Scores over 14 - Generally these patients are able to perform mobility manoeuvres alone and safely and are independent in basic ADL. |
first and fifth day after the surgery
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Change in 5 times sit to stand test
Time Frame: first and fifth day after the surgery
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The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times.
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first and fifth day after the surgery
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Change in Numeric pain rating scale
Time Frame: up to five days
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An 11-point scale scored from 0 to 10: 0 = no pain, 10= the most intense pain imaginable
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up to five days
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Chane in Quadriceps muscle strength
Time Frame: A 1 day before the surgery, first and fifth day after the surgery.
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muscle strength measure by dynamometer (N⋅m)
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A 1 day before the surgery, first and fifth day after the surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospitalization duration
Time Frame: At discharge (assessed up to day 10)
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Number of days of hospitalization after the surgery- taken from the patient's file
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At discharge (assessed up to day 10)
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Surgery duration
Time Frame: During the surgery
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minutes- taken from the patient's file
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During the surgery
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consumption of analgesics
Time Frame: At discharge (assessed up to day 10)
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taken from the patient's file
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At discharge (assessed up to day 10)
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occurrence of falls
Time Frame: At discharge (assessed up to day 10)
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throughout the hospitalization- taken from the patient's file
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At discharge (assessed up to day 10)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxford knee score questionnaire
Time Frame: A 1 day before the surgery
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The OKS is a patient self-completion PRO containing 12 questions on activities of daily living.
It provides a single summed score which reflects the severity of problems that the respondent has with their knee.
The OKS is scored 0-48 when Score 0-19 May indicate severe knee arthritis.
Score 20-29 May indicate moderate to severe knee arthritis.
Score 30-39 May indicate mild to moderate knee arthritis.
Score 40-48 May indicate satisfactory joint function.
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A 1 day before the surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Haim Shtarker, Dr, Head of the orthopedic department, Galilee medical center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHaifa-MEGK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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